Tin sulphide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-04-20 to 2010-04-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

, adopted 24 April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tin sulphide

EC Number:

215-248-7

EC Name:

Tin sulphide

Cas Number:

1314-95-0

Molecular formula:

SSn

IUPAC Name:

stannanethione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

New Zealand White rabbits were received from Covance Research Products, Inc., Denver, PA on 03/31/10 and acclimated for at least five days. Only animals in apparent good health were made available for study assignment. Prior to being selected for this study, both eyes of each animal were examined according to the Draize technique for any evidence of irritation or abnormalities of the cornea, iris and/or conjunctiva. A Mini-Maglite® flashlight equipped with a high intensity bulb was used to aid in the examination. Three rabbits (2 males- 1 female), free from evidence of ocular irritation or abnormalities, were assigned to this study without conscious bias. The animals were born on 12/12/09. The pretest body weight range was 2.6- 3.0 kg. The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed 1/cage in suspended cages. Paper bedding was placed beneath the cages and changed at least three times/week. Fresh PMI Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12-hour light/dark cycle and was kept clean and vermin free.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

The test article (0.1 mL equivalent (87.6 mg)) was used for the study, in a single dose.

Duration of treatment / exposure:

The eyes of the test animals were not washed out after the application of test item.

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

Three healthy New Zealand White rabbits (2 males- 1 female), free from evidence of ocular irritation and corneal abnormalities, were dosed with tin sulfide. The test article (0.1 mL equivalent (87.6 mg)) was placed into the conjunctival sac of one eye of each rabbit. The contralateral eye served as a control. The eyes were examined pretest and scored by the Draize technique at 1, 24, 48 and 72 hours postdose. The control eyes were observed at the same time periods. Sodium fluorescein dye procedures were used at the 24-hour observation interval. Observations for toxicity and pharmacological effects were recorded at each ocular observation period. Body weights were recorded pretest and at termination. The mean total scores for 24, 48 and 72 hours were calculated by adding the total score for each time period and dividing by the number of animals.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Mean total score

Basis:

mean

Time point:

other: 24 h

Score:

0.67

Max. score:

110

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: The "Max. score" gives the max. reachable score in the present test system.

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 10

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 11

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes after 1 hour, cleared in two animals by 24 hours and in all animals by 48 hours. The control eyes were normal at all observation periods. There were no abnormal physical signs noted during the observation period. Body weights increased in 2/3 animals and stayed the same in one animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Tin sulfide had no eye irritating/corrosive effect in an in vivo study according to OECD guideline 405.

Executive summary:

The eye irritating/corrosive properties of tin sulfide were determined in a study with rabbits according to OECD guideline 405. There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes after 1 hour, cleared in two animals by 24 hours and in all animals by 48 hours. There were no abnormal physical signs noted during the observation period. In summary, the mean total score at 24 hours was 0.67, at 48 and 72 hours it was 0.